FDA product code MUM: Stent, Metallic, Expandable, Duodenal
MUM is the FDA product code for stent, metallic, expandable, duodenal. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 6 510(k) submissions under MUM, 2 in the last five years, from 4 different applicants. The average 510(k) review took 149 days (median 112); 26 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Stent, Metallic, Expandable, Duodenal |
| Device class | Class II |
| Regulation | 21 CFR 878.3610 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for MUM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 143 |
| 2023 | 1 | 264 |
| 2025 | 1 | 26 |
Compare with all 510(k) review times · Search every MUM clearance
Top MUM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Taewoong Medical Co., Ltd. | 2 | 2025-03-31 |
| Cook Ireland, Ltd. | 2 | 2017-05-04 |
| Boston Scientific Corp | 1 | 2006-12-04 |
| Boston Scientific Scimed, Inc. | 1 | 1998-04-03 |
Most recent MUM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250663 | Taewoong Medical Co., Ltd. | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | 2025-03-31 | 26 |
| K223067 | Taewoong Medical Co., Ltd. | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | 2023-06-14 | 264 |
| K163468 | Cook Ireland, Ltd. | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | 2017-05-04 | 143 |
| K101530 | Cook Ireland, Ltd. | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | 2011-03-29 | 299 |
| K062750 | Boston Scientific Corp | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | 2006-12-04 | 81 |
Recalls for MUM devices
openFDA lists no recalls for product code MUM.
Frequently asked questions
What is FDA product code MUM?
MUM is the FDA product code for stent, metallic, expandable, duodenal. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel.
What device class is MUM?
Class II, regulation 21 CFR 878.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUM?
Across 6 cleared submissions the average was 149 days from receipt to decision (median 112).
Which companies have the most MUM clearances?
Taewoong Medical Co., Ltd. (2); Cook Ireland, Ltd. (2); Boston Scientific Corp (1); Boston Scientific Scimed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MUM
- Run a recall and safety report across every MUM manufacturer
- Watch product code MUM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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